Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke (SERICT-AIS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04027621 |
Recruitment Status :
Completed
First Posted : July 22, 2019
Last Update Posted : June 30, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Device: remote ischemic conditioning Device: sham remote ischemic conditioning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke |
Actual Study Start Date : | July 1, 2019 |
Actual Primary Completion Date : | July 1, 2020 |
Actual Study Completion Date : | July 20, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: RIC group
RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
|
Device: remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. |
Placebo Comparator: control group
Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
|
Device: sham remote ischemic conditioning
Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. |
- Frequency of adverse events during hospitalization [ Time Frame: 7 days ]All adverse events until day-7 or discharge (whichever is earlier)
- Frequency of adverse events during follow-up [ Time Frame: 3 months ]Severe adverse events through day-90 after the onset of acute ischemic stroke.
- National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge [ Time Frame: 7 days ]National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
- Changes of hematological indicators [ Time Frame: 24 hours ]Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.
- Changes of the function of dynamic cerebral autoregulation [ Time Frame: 10 days ]The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1) Age≥18 years, < 80 years, regardless of sex;
- 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- 3) Baseline NIHSS >= 5, and <= 25;
- 4) Baseline GCS ≥8;
- 5) Signed and dated informed consent is obtained
Exclusion Criteria:
- 1) Patients who undergo endovascular treatment;
- 2) mRS ≥ 2 before the onset of the disease;
- 3) Double upper limbs or lower limbs paralysis was found in this case;
- 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
- 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
- 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
- 7) Severe organ dysfunction or failure;
- 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
- 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
- 10) Those who have a history of atrial fibrillation;
- 11) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb#Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- 12) Pregnant or lactating women;
- 13) Previous remote ischemic conditioning therapy or similar treatment;
- 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
- 15) Severe hepatic and renal dysfunction;
- 16) Unwilling to be followed up or treated for poor compliance;
- 17) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
- 18) Other conditions that the researchers think are not suitable for the group.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027621
China, Jilin | |
The First Hospital of Jilin University | |
Chang chun, Jilin, China, 130000 |
Responsible Party: | Yi Yang, Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University |
ClinicalTrials.gov Identifier: | NCT04027621 |
Other Study ID Numbers: |
SERICT-AIS |
First Posted: | July 22, 2019 Key Record Dates |
Last Update Posted: | June 30, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |